BK virus

Main information

  • Trade name:
  • BK virus IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • BK virus IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222188
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222188

Vela Diagnostics Australia Pty Ltd - BK virus IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Vela Diagnostics Australia Pty Ltd

Postal Address

Level 9 Avaya House 123 Epping Road,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

9/04/2014

Product category

Medical Device Class 3

Status

Active

Approval area

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Vela Operations Singapore Pte Ltd

2-4/5/6 The Kendall 50 Science Park Road

Science Park II, , 117406

Singapore

Products

1. BK virus IVDs

Product Type

Effective date

9/04/2014

GMDN

CT758 BK virus IVDs

Intended purpose

The Sentosa SA BKV Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for

use in the detection and quantitation of BK virus (BKV) DNA using Sentosa SX101 instrument in

conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For human EDTA plasma, serum and

urine samples, Sentosa SX Virus Total Nucleic Acid Kit v2.0 is used for DNA extraction; and for human

EDTA whole blood samples, Sentosa® SX Whole Blood Kit is used for DNA extraction.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 09.11.2017 at 10:29:34 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

17-10-2018

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Lumpy skin disease: scientific and technical assistance on control and surveillance activities

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Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

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28-9-2018

Avian influenza overview May – August 2018

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Novel foods: a risk profile for the house cricket (Acheta domesticus)

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30-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

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FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak

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Procleix West Nile Virus (WNV) Assay

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Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

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23-5-2018

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

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The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV).

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22-8-2018

BTVPUR (Merial)

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3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

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Zalmoxis (MolMed S.p.A.)

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Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

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4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

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19-6-2018

Aftovaxpur Doe (Merial)

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Europe -DG Health and Food Safety

1-6-2018

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Active substance: Bluetongue Virus Serotype 2 antigen - Bluetongue Virus Serotype 4 antigen) - Withdrawal (sunset clause) - No Commission Decision

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Active substance: Three human monoclonal antibodies against the Ebola virus glycoprotein) - Orphan designation - Commission Decision (2018)3395 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/18

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Merial)

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Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 1 (Merial)

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BTVPUR AlSap 1 (Active substance: Bluetongue Virus Serotype 1 antigen) - Centralised - Withdrawal - Commission Decision (2018)3017 of Wed, 16 May 2018

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EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

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